(138 days)
Not Found
No
The summary describes a central station for displaying and managing patient data from monitors and telemetry systems. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on data collection, display, and printing.
No
The device is described as a "Clinical Information Central Station" that collects, displays, and prints patient data (physiological, demographic, non-medical) from a network of monitors and telemetry systems. It does not perform any therapeutic intervention or treatment. Its function is data management and display for clinicians.
No
The device collects and displays patient data (physiological, demographic, non-medical) from a network. It presents existing information in a centralized location for clinicians, but it does not perform any analysis or interpretation to diagnose a condition.
No
The device description explicitly states it is based on a "standard PC platform" and includes optional hardware components like a "2" Direct Digital Writer or a laser printer," indicating it is not solely software.
Based on the provided information, the CIC Pro Clinical Information Central Station is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect, display, and print physiological and patient data from monitors and telemetry systems. This data is derived from the patient's body (e.g., heart rate, waveforms) and is not obtained from in vitro examination of specimens derived from the human body (like blood, urine, or tissue).
- Device Description: The device is a central station based on a PC platform that displays and manages data from other medical devices. It doesn't perform any tests or analyses on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, or controls, which are typical components and functions of IVD devices.
The device is a clinical information system designed to centralize and display patient monitoring data, which falls under the category of medical devices used for patient care and monitoring, but not specifically for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The CIC Pro Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information. Physiological parameters and waveforms from GE Medical Systems Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed. The CIC Pro Central Station supports the ability to access information from GE Medical Systems Information Technologies' products in a web browser format. Additionally, CIC Pro Central Station supports the ability to access patient information collected from the Unity network and stored on a network server.
Product codes
DXJ, DSI
Device Description
The CIC Pro Central Station is based on a standard PC platform and provides centralized monitoring of all patients connected to GEMS IT monitors and telemetry transmitters. It may be configured to display up to four real-time waveforms per patient for up to 16 patients. Controls include the use of a computer mouse, keyboard and optional touch screen for precise touch control. Optional writers for the purpose of graphing waveforms and printing patient information include a 2" Direct Digital Writer or a laser printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonatal
Intended User / Care Setting
licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The CIC Pro platform and its applications comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:
. Requirements specification review
. Code inspections
. Software and hardware testing
. Safety testing
. Environmental testing
. Final validation
The results of these measurements demonstrated that the CIC Pro Central Station is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).
0
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510(k) Summary of Safety and Effectiveness
| Date: | November 28, 2005 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Contact Person: | Ronald N. Blaski |
| Regulatory Affairs Specialist | |
| GE Medical Systems Information Technologies | |
| 8200 West Tower Avenue | |
| Milwaukee, WI 53223 USA | |
| Phone: 414-362-2348 | |
| Fax: 414-362-2585 | |
| Device: Trade Name: | CIC Pro Clinical Information Center Central Station |
| Common/Usual Name: | Central Station Monitoring System |
| Classification Names: | |
| 21 CFR 870.2450 | Display, Cathode-ray Tube, Medical DXJ |
| 21 CFR 870.1025 | Detector and Alarm, Arrhythmia DSI |
| Predicate Device: | K032370 Clinical Information Center (CIC) Central Station |
| Device Description: | The CIC Pro Central Station is based on a standard PC platform and provides centralized monitoring of all patients connected to GEMS IT monitors and telemetry transmitters. It may be configured to display up to four real-time waveforms per patient for up to 16 patients. |
| Controls include the use of a computer mouse, keyboard and optional touch screen for precise touch control. Optional writers for the purpose of graphing waveforms and printing patient information include a 2" Direct Digital Writer or a laser printer. | |
| Intended Use: | The CIC Pro Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. |
| The CIC Pro Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information. | |
| Physiological parameters and waveforms from GE Medical Systems Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed. | |
| The CIC Pro Central Station supports the ability to access information from GE Medical Systems Information Technologies' products in a web browser format. Additionally, CIC Pro Central Station supports the ability to access patient information collected from the Unity network and stored on a network server. |
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The CIC Pro Central Station employs the same functional technology Technology: as the predicate devices.
Test Summary: The CIC Pro platform and its applications comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:
- . Requirements specification review
- . Code inspections
- . Software and hardware testing
- . Safety testing
- . Environmental testing
- . Final validation
Conclusion:
The results of these measurements demonstrated that the CIC Pro Central Station is as safe, as effective, and performs as well as the predicate device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
GE Medical Systems Information Technologies c/o Mr. Ronald N. Blaski Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukce, WI 53223
Re: K053356 Trade Name: CIC Pro Clinical Information Center Central Station, Version 5 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II (two) Product Code: DXJ Dated: Undated Received: April 17, 2006
Dear Mr. Blaski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Ronald N. Blaski
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blummenhof
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K053356
Device Name: CIC Pro Clinical Information Center Central Station
Indications for Use:
The CIC Pro Clinical Information Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment.
CIC Pro Clinical Information Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information.
Physiological parameters and waveforms from monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed.
The CIC Pro Clinical Information Center Central Station supports the ability to access information from CIC Pro Clinical Information Center Central Station' products in a web browser format. Additionally, CIC Pro Clinical Information Center Central Station supports the ability to access patient information collected from the Unity network and stored on a network server.
Prescription Use - -X (Part 21 CFR 801 Subpart D)
ANDAOR
(Over-The-Counter Use -(21 CFR 801 Subpart ( )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
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Bhemnnch
(Posted November 13, 2003)